Dilatrend tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

carvedilol

Available from:

Cheplapharm Arzneimittel GmbH

ATC code:

C07AG02

INN (International Name):

carvedilol

Dosage:

6,25mg

Pharmaceutical form:

tablets

Units in package:

(30/3x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-03-12

Patient Information leaflet

Leaflet Dilatrend AM
DRAFT (DATE) 20.10.2021 [13:15 uhr] (3)
DIMENSIONS 450/150 x 304,8 mm
COLOURS Pantone Black linework
MATERIAL NUMBER 90003304/10
FONT SIZE 8 pt
PRODUCT CODE DP
86067431 AM-CP (C80)
DILATREND
®
Carvedilol
ALPHA (Α) AND BETA (Β) ADRENERGIC RECEPTOR
BLOCKING AGENTS
1. DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Alpha (α) and beta (β) adrenergic receptor blocking
agents.
ATC CODE: C07AG02.
1.2
TYPE OF DOSAGE FORM
Tablets.
The tablet(s) can be divided into equal doses.
1.3
ROUTE OF ADMINISTRATION
Oral.
1.4
STERILE / RADIOACTIVE STATEMENT
Not applicable.
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: carvedilol.
_Tablets_
One 6.25 mg tablet contains 6.25 mg carvedilol.
List of excipients: Lactose monohydrate, Sucrose,
Povidone K25, Crospovidone type A, colloidal
anhydrous silica, Magnesium stearate, yellow iron
oxide [E 172].
One 12.5 mg tablet contains 12.5 mg carvedilol.
List of excipients: Lactose monohydrate, Sucrose,
Povidone K25, Crospovidone type A, colloidal
anhydrous silica, Magnesium stearate, yellow iron
oxide [E 172], red iron oxide [E 172].
One 25 mg tablet contains 25 mg carvedilol. List of
excipients: Lactose monohydrate, Sucrose,
Povidone K25, Crospovidone type A, colloidal
anhydrous silica, Magnesium stearate.
Excipient(s) with known effect: Each tablet contains
lactose monohydrate and sucrose.
2. CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
_Hypertension_
Carvedilol is indicated for the management of
essential hypertension. It can be used alone or in
combination with other anti-hypertensive agents
(e.g. calcium channel blockers, diuretics).
_Coronary heart disease_
Carvedilol has demonstrated clinical efficacy in
coronary heart disease.
_Chronic heart failure_
Unless a contraindication exists, carvedilol is
indicated for the treatment of all patients with stable
and symptomatic, mild, moderate and severe chronic
heart failure (CHF) of ischemic or non-ischemic
aetiology in combination with standard therapy
(including ACE inhibitors and diur

Summary of Product characteristics

1
DILATREND
®
Carvedilol
ALPHA (
Α
) AND BETA (
Β
) ADRENERGIC RECEPTOR BLOCKING AGENTS
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Alpha (
α
) and beta (β) adrenergic receptor blocking agents.
ATC CODE: C07AG02.
1.2
TYPE OF DOSAGE FORM
Tablets.
The tablet(s) can be divided into equal doses.
1.3
ROUTE OF ADMINISTRATION
Oral.
1.4
STERILE / RADIOACTIVE STATEMENT
Not applicable.
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: carvedilol.
_Tablets _
One 6.25 mg tablet contains 6.25 mg carvedilol. List of excipients:
Lactose monohydrate,
Sucrose, Povidone K25, Crospovidone type A, colloidal anhydrous
silica, Magnesium
stearate, yellow iron oxide [E 172].
One 12.5 mg tablet contains 12.5 mg carvedilol. List of excipients:
Lactose monohydrate,
Sucrose, Povidone K25, Crospovidone type A, colloidal anhydrous
silica, Magnesium
stearate, yellow iron oxide [E 172], red iron oxide [E 172].
One 25 mg tablet contains 25 mg carvedilol. List of excipients:
Lactose monohydrate,
Sucrose, Povidone K25, Crospovidone type A, colloidal anhydrous
silica, Magnesium
stearate.
Excipient(s) with known effect: Each tablet contains lactose
monohydrate and sucrose.
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
_Hypertension _
Carvedilol is indicated for the management of essential hypertension.
It can be used alone
or in combination with other anti-hypertensive agents (e.g. calcium
channel blockers,
2
diuretics).
_Coronary heart disease _
Carvedilol has demonstrated clinical efficacy in coronary heart
disease.
_Chronic heart failure _
Unless a contraindication exists, carvedilol is indicated for the
treatment of all patients
with stable and symptomatic, mild, moderate and severe chronic heart
failure (CHF) of
ischemic or non-ischemic aetiology in combination with standard
therapy (including
ACE inhibitors and diuretics with or without digitalis).
2.2
DOSAGE AND ADMINISTRATION
_Method of administration _
The tablets are to be swallowed with sufficient fluid.
_Duration of treatment _
Treatment with c